The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
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|ClinicalTrials.gov Identifier: NCT03628937|
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obesity Puberty, Precocious||Dietary Supplement: Decaffeinated Green Tea Polyphenol Other: Placebo control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls|
|Actual Study Start Date :||August 28, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: Intervention group
Interventions: Decaffeinated green tea polyphenol capsule (400 mg, EGCG accounted for 50%) will be given to participants in intervention group, and they need take it once a day after breakfast for 12 weeks.
Decaffeinated green tea polyphenol: 400mg/capsule, 1 capsule/d, qd, 12 weeks
Dietary Supplement: Decaffeinated Green Tea Polyphenol
Intervention group will be given decaffeinated green tea polyphenol capsules (400 mg, EGCG accounted for 50%). Participants need take it once a day after breakfast for 12 weeks.
Placebo Comparator: Control group
The placebo control group will be given placebo capsules, and participants need take it once a day after breakfast for 12 weeks.
Other: Placebo control
The starch capsule was used as a placebo control, which has the same dosage, appearance and smell compared to decaffeinated green tea polyphenol capsule. The use frequency and duration are consistent with intervention group.
- The incidence of Precicous Puberty in the intervention groups and the placebo group. [ Time Frame: about two years ]Female precocious puberty is defined as the development of secondary sexual characteristics before the age of 8 or menarche before the age of 10. In our study, after intervention, for girls under 8 years of age, we recorded their rate of secondary sexual characteristics at 8 years of age; and for girls under 10 years of age, we recorded their rate of menarche at 10 years of age. The difference in the incidence of precocious puberty between the two groups is the primary outcome.
- The average age of onset of menarche in two groups [ Time Frame: an average of 4 years ]Record the age of the onset of menarche of each girl and comparing the average age between two groups, to explore whether green tea polyphenols could delay the early pubertal development.
- The change in BMI at week 12 intervention from the baseline [ Time Frame: 12 weeks ]Obesity is an important contributing factor to the early onset of puberty for girls. Green tea polyphenols may prevent precocious puberty by controlling body weight and reducing serum leptin level.
- The change of breast tissue volume at week 12 intervention from the baseline [ Time Frame: 12 weeks ]These indicator is important indicators related to sexual development.
- The change of uterus volume at week 12 intervention from the baseline [ Time Frame: 12 weeks ]These indicator is important indicators related to sexual development.
- The change of the number of follicles with diameter of > 4mm follicles in ovary at week 12 intervention from the baseline [ Time Frame: 12 weeks ]These indicator is important indicators related to sexual development.
- The change of serum sex hormone levels at week 12 intervention from the baseline [ Time Frame: 12 weeks ]These indicators are important indicators related to sexual development.
- The status of liver and kidney function at the baseline and after 12 weeks intervention [ Time Frame: 12 weeks ]To indentify the safety of green tea polyphenol intake for obesegirls
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628937
|Contact: Xiuhua Shen, Professoremail@example.com|
|Contact: Luyao Xie, Masterfirstname.lastname@example.org|
|Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200092|
|Contact: Xiuhua Shen, Doctor 13916910428 email@example.com|
|Study Chair:||Xiuhua Shen, Professor||Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine|